Intent-to-treat

Strategy for conducting a trial and analyzing data. The strategy implies “analyze as randomized” regardless of adherence or treatment received.


According to Fisher et al. (1990), the ITT analysis includes all randomized patients in the groups to which they were randomly assigned, regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol 1).

The intention-to-treat analysis analyzes the patient according to which treatment they were assigned, even though they have received another treatment than the originally randomized one (crossover). Other options will be according to which treatment they received, named as treatment analysis.

see Reproducibility.

1)
Fisher LD, Dixon DO, Herson J, Frankowski RK, Hearron MS, Peace KE. Intention to treat in clinical trials. In: Peace KE, editor. Statistical issues in drug research and development. New York: Marcel Dekker; 1990. pp. 331–50.